MAUDE Adverse Event Report: BAUSCH + LOMB 2.4 MM PHACO ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and sterilization could not be performed at this time since the lot number is unknown.The product was returned and evaluated.One small plastic specimen cup was returned in a plastic biohazard bag.The original packaging was not returned.The part number and lot number could not be verified or determined.The specimen cup contained a mist-yellow irrigation sleeve, a wedge-shaped swab, and a small round particle.Visual inspection found the irrigation sleeve dirty with particulates and dried solutions visible all over it.The small round mist-yellow, colored particle was stuck to the inside wall of the plastic specimen cup.Microscopic examination was performed and found the irrigation sleeve is not torn.The round, disc-like particle appears to be the same color as the irrigation sleeve and is similar in shape and size to the irrigation port holes on the sides of the tip of the irrigation sleeve.The particle has the appearance of the hole punch remnant.This investigation is ongoing.
Event or Problem Description
A user facility reported that during two separate cataract surgeries, performed on the same day, the surgeon found a cut from one of the ports from the yellow sleeve in the eye.The surgeon extracted particles immediately when noticed.There were no complications or delays in the surgeries.Only one particle was returned for evaluation.
Additional Manufacturer Narrative
The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Additional Manufacturer Narrative
Correction h10: complaint description is consistent with the presence of an irrigation hole punch from the yellow irrigation sleeve associated with this device.Supplier investigation request was issued to the supplier.The supplier has taken actions to resolve the issue.The sir is currently being monitored for effectiveness, with closure expected within q2 2025.

• Brand Name: 2.4 MM PHACO ACCESSORY PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22020314
• Report Number: 0001920664-2025-00067
• Device Sequence Number: 9483976
• Product Code: HQC
• UDI-Device Identifier: 20757770059618
• UDI-Public: (01)20757770059618
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BL3124S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 06/30/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/24/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown